Exploratory Study on Artifact Denoising of Cerebral Blood Flow and EEG Data in Ambulance Settings

NCT ID: NCT06701708

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-12-31

Brief Summary

The purpose is to assess the extent of digital noise occurring during the measurement of cerebral blood flow and EEG in healthy adults within an ambulance setting and to explore the possibility of identifying and correcting abnormal patterns.

Conditions

Normal; EEG; FNIRS

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Normal

Participants are not assigned to interventions based on a protocol.

Intervention Type: OTHER

Participants are not assigned to interventions based on a protocol.

Interventions

Participants are not assigned to interventions based on a protocol.

Participants are not assigned to interventions based on a protocol.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy adults aged 19 to 80 years.
• Individuals without chronic diseases (e.g., Stage 2 hypertension, cardiovascular disease, chronic kidney disease, chronic pulmonary disease, etc.).
• Individuals without mental health disorders (e.g., depression, schizophrenia, etc.).
• Individuals not taking medications that could affect cerebral hemodynamics, such as antihypertensives, anticoagulants, antiplatelets, antidepressants, etc.

Individuals who can read and understand the participant information and consent form and have sufficient language ability to respond to questionnaires.

• Individuals who voluntarily decide to participate in the clinical study, provide written consent on the participant consent form, and are able to participate throughout the entire duration of the clinical study.

Exclusion Criteria

• Individuals who have experienced head trauma in the past 6 months.
• Individuals with ongoing severe chronic diseases (e.g., heart failure, chronic kidney disease, chronic pulmonary disease, etc.).
• Individuals with severe mental health disorders such as schizophrenia, severe depression, bipolar disorder, etc.
• Individuals currently taking medications that may affect the study (e.g., antihypertensives, anticoagulants, antiplatelets, antidepressants, etc.).
• Individuals who have participated in a clinical trial and taken experimental drugs within the past 30 days.
• Women who are pregnant or breastfeeding.
• Individuals who have undergone major surgery in the past 6 months.
• Individuals with acute infections or inflammatory diseases.
• Individuals with cognitive impairment or dementia.
• Individuals with neurological disorders.
• Individuals who lack understanding of the study procedures or who have not voluntarily consented to participate.
• Individuals with clinically significant findings that the study principal investigator or responsible medical personnel determines to be inappropriate for participation in this study.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yong-il Shin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Youjin Jeong Youjin Jeong

Role: CONTACT

ctccrc@pnuyh.co.kr

082-055-360-4159

Other Identifiers

11-2024-058

Identifier Type: -

Identifier Source: org_study_id